Clinical trial · Interventional
Comparison Trial of Open-tip Pulsed Needle Biopsy and Conventional Core Biopsy in Axillary Lymph Nodes
NCT04500262CI-TRIAL-00066835COMPULSEunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study is to compare performance and safety of a newly developed 14-gauge open-tip pulsed biopsy needle with a conventional 14-gauge core biopsy needle for sampling of radiologically indeterminate or suspicious axillary lymph nodes in women with radiologically suspected breast cancer. This is a Sponsor-initiated multicentre randomised trial. At the time of radiological breast cancer diagnosis women with ultrasonically abnormal lymph nodes undergo axillary sampling using the NeoNavia biopsy system or a common CNB device. This is in accordance with clinical routine and current clinical guidelines. The NeoNavia biopsy system is approved for use in the axillary lymph nodes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Core needle biopsy (CNB) | Device | — | UNRESOLVED |
| Open-tip pulsed needle biopsy (NeoNavia Biopsy System) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Open-tip pulsed needle biopsy
- description
- Biopsy procedure using the NeoNavia biopsy system. The needle used in this study is of the same outside diameter as a standard biopsy needle used in the breast or axilla (14-gauge) but does not have a notched trochar like a conventional spring-loaded device. It does not have a redundant portion of needle beyond the sampling zone and takes full circumference cylindrical cores. A pneumatic system powered by a floor-standing base unit connected via a handheld driver to the biopsy device provides impulses to the needle, allowing the operator to advance the needle through tissue with little manual force (NeoNavia biopsy system, NeoDynamics, Sweden).
- interventionNames
- Device: Open-tip pulsed needle biopsy (NeoNavia Biopsy System)
- type
- ACTIVE_COMPARATOR
- label
- Conventional core needle biopsy (CNB)
- description
- Standard of care core needle biopsy used currently in clinics for biopsy procedures
- interventionNames
- Device: Core needle biopsy (CNB)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women in screening and symptomatic clinics aged 18 years or older with breast masses scored as 1 of the following: * M3, M4 or M5 (mammographically uncertain, suspicious or highly suspicious of malignancy) * MRI5 (highly suspicious of malignancy on MRI) * U3, U4 or U5 (ultrasonically uncertain, suspicious or highly suspicious of malignancy) * have histologically proven breast cancer * who have ipsilateral axillary lymph nodes which are described as indeterminate or suspicious for metastatic disease and indicated for biopsy, as determined by individual breast unit criteria * are able to give informed consent for the study Exclusion Criteria: * Previous ipsilateral axillary surgery * Target lymph node not suitable for needle biopsy due to its close proximity to critical structures such as major blood vessels * Unable to give written informed consent in English
References
Publications (20)
- BACKGROUNDHoussami N, Turner RM. Staging the axilla in women with breast cancer: the utility of preoperative ultrasound-guided needle biopsy. Cancer Biol Med. 2014 Jun;11(2):69-77. doi: 10.7497/j.issn.2095-3941.2014.02.001. PMID 25009748
- BACKGROUNDTopps AR, Barr SP, Pikoulas P, Pritchard SA, Maxwell AJ. Pre-operative Axillary Ultrasound-Guided Needle Sampling in Breast Cancer: Comparing the Sensitivity of Fine Needle Aspiration Cytology and Core Needle Biopsy. Ann Surg Oncol. 2018 Jan;25(1):148-153. doi: 10.1245/s10434-017-6090-1. Epub 2017 Oct 23. PMID 29063297
- BACKGROUNDBritton PD, Provenzano E, Barter S, Gaskarth M, Goud A, Moyle P, Sinnatamby R, Wallis M, Benson JR, Forouhi P, Wishart GC. Ultrasound guided percutaneous axillary lymph node core biopsy: how often is the sentinel lymph node being biopsied? Breast. 2009 Feb;18(1):13-6. doi: 10.1016/j.breast.2008.09.003. Epub 2008 Nov 7. PMID 18993074
- BACKGROUNDMacaskill EJ, Purdie CA, Jordan LB, Mclean D, Whelehan P, Brown DC, Evans A. Axillary lymph node core biopsy for breast cancer metastases -- how many needle passes are enough? Clin Radiol. 2012 May;67(5):417-9. doi: 10.1016/j.crad.2011.10.006. Epub 2011 Nov 26. PMID 22119100
- BACKGROUNDMaxwell AJ, Bundred NJ, Harvey J, Hunt R, Morris J, Lim YY. A randomised pilot study comparing 13 G vacuum-assisted biopsy and conventional 14 G core needle biopsy of axillary lymph nodes in women with breast cancer. Clin Radiol. 2016 Jun;71(6):551-7. doi: 10.1016/j.crad.2016.02.024. Epub 2016 Mar 31. PMID 27040801
- BACKGROUNDGiuliano AE, Hunt KK, Ballman KV, Beitsch PD, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, McCall LM, Morrow M. Axillary dissection vs no axillary dissection in women with invasive breast cancer and sentinel node metastasis: a randomized clinical trial. JAMA. 2011 Feb 9;305(6):569-75. doi: 10.1001/jama.2011.90. PMID 21304082